Russia's Constitutional Court confirms constitutionality of compulsory patent licensing for pharmaceuticals

Ruling No. 13-П, 12 March 2026  •  Sanofi Russia JSC and Vertex Pharmaceuticals Incorporated

On 12 March 2026, the Constitutional Court of the Russian Federation (CCRF) issued Ruling No. 13-П on the constitutionality of Article 1362 of the Civil Code, which governs compulsory patent licensing. The provision was upheld; however, the Court issued a universally binding interpretation that substantially affects the position of patent holders in Russia.

Background

The case arose from a dispute involving Trikafta (Vertex Pharmaceuticals, USA) — at the time of the proceedings the only registered multi-component cystic fibrosis drug in Russia, used by nearly 4,400 patients. Russian company MIK obtained a court order granting it a compulsory licence over 12 of Vertex's Russian patents, permitting it to supply Argentine generic Trilexa. The applicants — Sanofi and Vertex — challenged the constitutionality of the provision itself, arguing that it was insufficiently precise.

The Court's position

The CCRF rejected the unconstitutionality arguments, noting that the use of evaluative concepts in legislation does not in itself render a provision uncertain. At the same time, the Court issued a binding interpretation of Article 1362 of the Civil Code. Its key elements are set out below.

Key legal holdings

1. Pricing policy as a form of insufficient exploitation. This is the most practically significant holding of the ruling. The Court expressly stated: where a patent holder is willing to supply a life-critical drug on the Russian market, but only at an extremely high price, and a bioequivalent alternative is available at a substantially lower price, such conduct may be characterised as insufficient exploitation of the patent — giving courts the power to grant a compulsory licence. The absence of formal bad faith on the part of the patent holder is immaterial.

2. Systematic non-participation in public procurement. Repeatedly declining to participate in government procurement procedures on the grounds that the price cap is unacceptable also constitutes a sign of insufficient exploitation — particularly where procurement tenders are the only mechanism for supplying the product in the given jurisdiction.

3. Compulsory licensing remains an exceptional measure. The Court emphasised that the provision does not permit broad application without adequate judicial findings. The existence of a significant public interest — tied to constitutionally protected values (life, health, security) — must also be established.

4. Burden of proof. The licence applicant must prove the market shortage and the relevance of the requested patents to the product to be manufactured. The patent holder, for its part, is entitled and expected to rebut the relevance of specific patents — procedural passivity risks resulting in unwarranted requests being granted.

5. Scope of the licence. The scope is determined by actual market need. Where significant public interest involves the protection of life and health, the scope may be defined by reference to overall current demand — not limited to the narrow quantified 'shortfall'.

6. Remuneration. Royalties are set by the court by reference to comparable market transactions and the patent holder's actual losses. The specific characteristics of pharmaceutical R&D and actual costs of bringing a drug to market may be taken into account, at least in part, when calculating compensation.

Significance

The ruling provides clearer contours to the constitutional doctrine on compulsory patent licensing in the pharmaceutical sector in Russia. It applies by analogy to other sectors, with due account for their particular features. The Supreme Court is now in a position to consolidate practice under Article 1362 of the Civil Code; the legislature may further specify the conditions for granting licences.

📌The Ruling (original text)